OneSource Specialty Pharma Limited, a multi-modality specialty pharmaceutical contract development and manufacturing organisation (CDMO), has announced a strategic manufacturing partnership with Sweden-based Xbrane Biopharma AB (Nasdaq: XBRANE), a leading biotechnology firm. The collaboration will focus on the commercial production of Xbrane’s biosimilar portfolio.

Xbrane’s biosimilar pipeline targets an estimated EUR 23 billion in annual peak sales of the reference biologics. Its lead candidate, Ximluci—a biosimilar of ranibizumab—has already received market authorisation in Europe and was launched in 2023. The product is currently under regulatory review for entry into the United States market.

Under the agreement, Xbrane will transfer the technology for selected biosimilars to OneSource’s state-of-the-art integrated Drug Substance and Drug Product (DS/DP) facility located in Bangalore, India. This move is aimed at bolstering Xbrane’s global supply chain and enhancing the regulatory readiness of OneSource’s biologics infrastructure. It is expected to accelerate approvals from regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

As part of the collaboration, OneSource has also taken part in Xbrane’s most recent funding round, underlining the long-term strategic alignment between the two firms.

Neeraj Sharma, Managing Director and CEO of OneSource Specialty Pharma, commented, “The partnership with Xbrane reflects our shared ambition to drive broader access to cutting-edge biologics worldwide. Xbrane’s proven success in biosimilar development, combined with OneSource’s fully integrated biologics platform, creates a strong foundation for global impact. We are pleased to support the scale-up of high-quality biosimilars and advance our vision of being a trusted partner to the world’s leading biotech companies.”

Martin Åmark, CEO of Xbrane Biopharma, added, “Our partnership with OneSource gives us access to top-tier, cost-competitive manufacturing and expertise for our biosimilars. This is essential for our global competitiveness and our commitment to providing affordable medicines to patients and payers.”

The collaboration is expected to enhance the reach of affordable biosimilar therapies globally, while also positioning OneSource as a leading biologics CDMO with strong regulatory and manufacturing capabilities.